Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier: A Randomized Trial

Autor: Amandine Rubio, Laurent Ameye, Jean Michel Hascoët, Bernard Guillois, Elie Saliba, Jonathan Jaeger, Johannes Spalinger, Fabio Mosca, Claude Billeaud, Nicholas P. Hays, Jean Charles Picaud, Umberto Simeoni, M. Radke, Jacques Rigo, Virginie de Halleux
Rok vydání: 2017
Předmět:
Male
0301 basic medicine
growth
Nutritional Status
Weight Gain
law.invention
03 medical and health sciences
0302 clinical medicine
Double-Blind Method
Randomized controlled trial
law
030225 pediatrics
Outcome Assessment
Health Care

medicine
Humans
Infant
Very Low Birth Weight

low birth weight
Food science
Infant Nutritional Physiological Phenomena
Biomarkers/metabolism
Dietary Fats
Dietary Proteins
Female
Food
Fortified

Infant Care/methods
Infant
Newborn

Infant
Premature/growth & development

Infant
Premature/metabolism

Infant
Very Low Birth Weight/growth & development

Infant
Very Low Birth Weight/metabolism

Milk
Human

Nutrition Assessment
Outcome Assessment (Health Care)
Nutritional biomarkers
030109 nutrition & dietetics
business.industry
Original Articles: Nutrition
Gastroenterology
human milk
food and beverages
Human milk fortifier
Docosahexaenoic acid
Infant Care
Pediatrics
Perinatology and Child Health

Energy density
Nutrition physiology
medicine.symptom
business
Weight gain
Biomarkers
Infant
Premature
Zdroj: Journal of pediatric gastroenterology and nutrition, vol. 65, no. 4, pp. e83-e93
Journal of Pediatric Gastroenterology and Nutrition
ISSN: 1536-4801
0277-2116
DOI: 10.1097/mpg.0000000000001686
Popis: Objectives: The aim of this study was to assess growth and nutritional biomarkers of preterm infants fed human milk (HM) supplemented with a new powdered HM fortifier (nHMF) or a control HM fortifier (cHMF). The nHMF provides similar energy content, 16% more protein (partially hydrolyzed whey), and higher micronutrient levels than the cHMF, along with medium-chain triglycerides and docosahexaenoic acid. Methods: In this controlled, multicenter, double-blind study, a sample of preterm infants ≤32 weeks or ≤1500 g were randomized to receive nHMF (n = 77) or cHMF (n = 76) for a minimum of 21 days. Weight gain was evaluated for noninferiority (margin = –1 g/day) and superiority (margin = 0 g/day). Nutritional status and gut inflammation were assessed by blood, urine, and fecal biochemistries. Adverse events were monitored. Results: Adjusted mean weight gain (analysis of covariance) was 2.3 g/day greater in nHMF versus cHMF; the lower limit of the 95% CI (0.4 g/day) exceeded both noninferiority (P
Databáze: OpenAIRE